A Review: On Scale-Up Factor Determination of Rapid Mixer Granulator
By P.Yadav, J.S.Chauhan, P.Kannojia, N. K Jain, V.Tomar
Today the production of Pharmaceutical granules is still based on the batch concept. In the early stage of the development of a solid dosage form the batch size is small. In later stage the size of the batch produced in the pharmaceutical production may be up to 100 times larger. Thus scale-up process is an extremely important one. Unfortunately in many cases the variety of the equipment involved does not facilitate the task of scale-up. During the scale-up process the quantity of the granules may change. A change in granule size distribution, final moisture content, friability, compressibility and compactibility of the granules may strongly influence the properties of the final tablet, such as tablet hardness, tablet friability, disintegration time, dissolution rate of the active substance, and aging of the tablet. In the following sections, the scale up process is analyzed taking into mathematical considerations of scale up theory, the search for scale up invariants, the establishment of in-process control methods. This paper describes an overview of granulation, rapid mixer granulator, Scale up in the field of granulation, various approaches used for scale up determination of Rapid Mixer Granulator, process variables, methods for end point determination & analysis of granulation process.
Key words: Scale-up, rapid mixer granulator , variables, end point determination
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